An interventional study of Repeated tactile stimulation and Selective tactile stimulation in Infant, Premature, Diseases and Birth, Preterm, sponsored by Leiden University Medical Center. Recruiting at 43 sites in 19 countries. Open to participants aged Up to 32 Weeks. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by Leiden University Medical Center · Not applicable, Interventional, and Treatment
The aim of this study is to determine the effect of repetitive tactile stimulation compared to selective stimulation on oxygenation of the infant at 5 minutes after birth. Infants born before 32 weeks of gestation will be included in this trial. This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation. This design is appropriate to test the effect of an intervention that encompasses a behavioral aspect - in this case the performance of tactile stimulation.
Rationale: A randomised study demonstrated that preterm infants who received repetitive stimulation at birth (10 second episodes of stroking of the soles of the feet and/or back, followed by 10 seconds rest) showed an increase in respiratory effort. This may in turn improve clinical outcomes as improved breathing effort may reduce the need for invasive respiratory support. Tactile stimulation can be immediately and easily performed at birth at no extra cost. It therefore has great potential to be implemented in delivery rooms (DRs) worldwide.
Objective: To determine the effect of repetitive tactile stimulation compared to selective stimulation on oxygenation of the infant at 5 minutes after birth.
Study design: This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation. This design is appropriate to test the effect of an intervention that encompasses a behavioral aspect - in this case the performance of tactile stimulation.
Study population: Infants born before 32 weeks of gestation will be included in this trial.
Intervention: At the start of the study, each participating centre will perform selective tactile stimulation in accordance with international guidelines, as is their usual practice. Clinicians will gently rub the back, chest, extremities or soles of the feet if they consider the breathing of the infant to be insufficient or absent. In the second stage of the study, centres will be randomised to switch their stimulation approach to repetitive stimulation. Clinicians will then gently rub the back, chest, extremities or soles of the feet for 10 seconds. To avoid extinction of the stimulatory effect (reflex), every 10 second period of stimulation will be followed by 10 seconds of rest (no stimulation). Repetitive stimulation will be performed for the first 5 minutes of life, or longer if the breathing is still considered insufficient or absent.
Main study parameter: The proportion of infants with pre-ductal oxygen saturation (SpO2) ≥ 80%.
88 studies on the registry are indexed under Infant, Premature, Diseases; 12 are open to participants now.
This study's planned enrollment of 3,280 is above the median of 63 across 57 interventional studies indexed under Infant, Premature, Diseases.
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Exclusion Criteria:
At the start of the study, selective tactile stimulation will be performed at each participating centre in accordance with international guidelines. Clinicians will gently rub the back, chest, extremities or soles of the feet if they consider the breathing of the infant to be insufficient or absent. All other procedures in the delivery room and NICU will be performed according to international and local guidelines.
Procedure: Selective tactile stimulation
For each centre, a lot will be drawn which indicates the month in which the protocol for tactile stimulation changes from selective stimulation to repetitive stimulation. Repetitive stimulation is defined as gently rubbing the soles of the feet, back, chest, or extremities for 10 seconds. To prevent extinction of the stimulatory effect (reflex), every 10 second period of stimulation will be followed by 10 seconds rest (no stimulation). The repetitive stimulation will be performed for the first 5 minutes after birth, or longer if the breathing is still considered insufficient or absent. All other procedures in the delivery room and NICU will be performed according to international and local guidelines.
Procedure: Repeated tactile stimulation
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See arm
SpO2>80
Proportion of infants with pre-ductal SpO2 \>80%
Time frame: At 5 minutes of life
Heart rate
Heart rate
Time frame: At 5 minutes after birth
Number of infants who received CPAP <10min
Number of infants who received continuous positive airway pressure
Time frame: Within 10 minutes after birth
Number of infants who received PPV <10min
Number of infants who received positive pressure ventilation
Time frame: Within 10 minutes after birth
Number of infants who were intubated <10min
Number of infants who were endotracheally intubated
Time frame: Within 10 minutes after birth
Number of infants who received chest compressions <10min
Number of infants who received chest compressions \<10min
Time frame: Within 10 minutes after birth
Number of infants who were administered adrenaline <10min
Adrenaline use
Time frame: Within 10 minutes after birth
Number of infants who were administered volume expansion <10min
Number of infants who were administered volume expansion \<10minv
Time frame: Within 10 minutes after birth
Max FiO2
Maximum FiO2
Time frame: In the first 10 minutes after birth
Death <10min
Death \<10min
Time frame: Within 10 minutes after birth
Number of infants who were supported by CPAP in first week
CPAP use in the NICU
Time frame: In the first week after birth
Number of infants who received surfactant in first week
Surfactant administration via INSURE, LISA or ET tube
Time frame: In the first week after birth
Surfactant doses
Number of surfactant doses administered
Time frame: In the first week after birth
Number of infants who were mechanically ventilated
Mechanical ventilation
Time frame: In the first week after birth
Number of infants with abnormalities on the first cranial ultrasound
Abnormalities on first cranial ultrasound (IVH/PVL)
Time frame: In first week after birth
Death
Mortality
Time frame: In the first week after birth
Cord clamping time
The time after birth at which the cord is clamped
Time frame: During resuscitation at birth
Congenital anomalies
Whether the infant has congenital anomalies, e.g. diaphragmatic hernia, oesophageal atresia, cyanotic heart disease
Time frame: At birth
Gestational age
gestational age in weeks and days
Time frame: At birth
Gender
Gender of the infant
Time frame: At birth
Mode of delivery
Mode of delivery
Time frame: At birth
Doses of antenatal steroids
Number of doses of antenatal steroids administered
Time frame: Before birth
Maternal magnesium sulphate
Whether maternal magnesium sulphate was administered
Time frame: Before birth
Maternal general anaesthesia
Whether maternal general anaesthesia was administered
Time frame: Before birth
Complications during pregnancy
Whether there were any complications during pregnancy, e.g. premature prolonged rupture of membranes, chorioamnionitis, pre-eclampsia, placental abruption, twin-to-twin transfusion syndrome, hydrops fetalis, feto-maternal haemorrhage
Time frame: Before birth
Plan to share: Undecided
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